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FDA Claims Sole Authority Over Naming Of US-Licensed Biologics

 
• By Sue Sutter

Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.

The US FDA asserts its full authority over biological product nonproprietary naming and justifies its final guidance requirement for distinguishable, nonmeaningful suffixes in a recent response to several industry citizen petitions.

A response to the Generic Pharmaceutical Association (GPhA), Sandoz Inc. and Johnson & Johnson lays out...

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More from Biosimilars & Generics

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• By Dean Rudge

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Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
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Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

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• By Neena Brizmohun

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